Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as IGIV-C 10%, Gamunex®, IGIVnex®, Gaminex, IVIG, BAY 41-1000, TAL-05-00004, NDC 13533-645-12
IGIV-C · 4 trials · 4 indications
The primary PK endpoint (steady-state AUC values) analysis was performed using analysis of variance (ANOVA) using PK data from a total of 49 subjects from the IV phase and 39 subjects from the SC phase.
Mean Change in Quantitative Myasthenia Gravis (QMG) Scale Score from Baseline (Day 0) to Day 14. The minimum and maximum scores of the QMG Scale are 0 and 39, respectively, and a higher score means a worse outcome.
To measure improvement in MG symptoms by the mean change in QMG total score from Baseline (Week 0) to Week 24 as compared to placebo. Evaluators score 13 individual items (range from 0=best to 3=worst) and the individual scores are added together for the total score (range 0-39). An average 3-point improvement in QMG score indicates clinically meaningful improvement.
The average daily CS dose was derived for each subject at each scheduled visit based on the prescribed dose and the time interval taking into account any prescribed dose changes between routinely scheduled visits. Subjects who discontinued the study early with adverse outcomes related to MG were considered as not achieving a 50% or greater reduction. The missing dose reduction at Week 39 was imputed using the worst observation carried forward (WOCF) method. For subjects who did not have CS dose prescribed at Week 39 due to other reasons, the last observation carried forward (LOCF) method was used to impute the prescribed CS dose at Week 39. Baseline was defined as the last non-missing measurement taken prior to first dose of study medication. The percent of subjects achieving ≥50% reduction in CS dose from baseline to Week 39 is presented for each treatment group overall and for the baseline daily prednisone equivalent dose level stratification categories.
| Arm | Type | Description |
|---|---|---|
| IGIV-C 10% | ACTIVE_COMPARATOR | IV dose of Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified (Grifols) |
| IGSC 20% | EXPERIMENTAL | Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (Grifols) |
| IGIV-C Treatment | EXPERIMENTAL | In this arm, subjects with myasthenia gravis exacerbations were treated with an IV dose of 2 g/kg of IGIV-C, which was administered over 2 consecutive days at a dose of 1 g/kg per day. |
| IGIV-C | EXPERIMENTAL | IGIV-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified. An initial loading dose of 2 g/kg of body weight will be administered at Baseline (Week 0, Visit 1) followed by maintenance doses of 1 g/kg of body weight administered every third week through Week 21 (Visit 8). |
| Placebo | PLACEBO_COMPARATOR | Placebo: Sterile 0.9% sodium chloride injection or equivalent. Placebo will be infused at the Baseline/Week 0 Visit (Visit 1) using the same volume as would be required for the IGIV-C loading dose. Subsequent placebo maintenance doses will be matched in volume to the IGIV-C maintenance doses and administered every third week until Week 21 (Visit 8). |
| Name | Type | Description |
|---|---|---|
| IGIV-C 10% | BIOLOGICAL | IGIV-C 10% infusions every 3 to 4 weeks based on previous IgG regimen |
| IGSC 20% | BIOLOGICAL | IGSC 20% weekly infusions with dose calculated based on previous IgG regimen |
| IGIV-C | BIOLOGICAL | An IV dose of 2 g/kg of IGIV-C was administered over 2 consecutive days at a dose of 1 g/kg per day. |
| Placebo | DRUG | - |
Inclusion Criteria: * Pre-existing diagnosis of primary immunodeficiency with features of hypogammaglobulinemia requiring IgG replacement therapy * No serious bacterial infection within the last 3 months prior to or during Screening * Currently on IgG replacement therapy (via IV or SC infusion) for...
IGIV-C is an investigational therapy developed by Grifols, S.A. for immune-mediated and immunodeficiency conditions. It has been studied in generalized myasthenia gravis, myasthenia gravis exacerbations, and primary immunodeficiency. The program includes completed Phase 2 and Phase 3 clinical trials.
IGIV-C has been studied for generalized myasthenia gravis, myasthenia gravis exacerbations, and primary immunodeficiency. Clinical trials enrolled adults with these conditions, including corticosteroid dependent patients with generalized myasthenia gravis. It remains investigational and is not described as approved for these indications.
IGIV-C is developed by Grifols, S.A., which trades under the ticker GRFS. The company sponsored the clinical trials evaluating IGIV-C in myasthenia gravis and primary immunodeficiency.
IGIV-C has completed Phase 2 and Phase 3 clinical trials. The Phase 2 studies evaluated it in generalized myasthenia gravis, while Phase 3 studies covered myasthenia gravis exacerbations and primary immunodeficiency. It is an investigational agent still in clinical development.
Completed trials include NCT02473952 and NCT02473965 in generalized myasthenia gravis, NCT02413580 in myasthenia gravis exacerbations, and NCT02604810 in primary immunodeficiency. These studies were conducted across sites in the United States, Canada, and multiple European countries.
Yes, IGIV-C 10% is another name for IGIV-C. Both refer to the same Grifols, S.A. investigational product studied in myasthenia gravis and primary immunodeficiency clinical trials.